Corbus Pharmaceuticals Holdings, Inc.
Corbus Pharmaceuticals Holdings, Inc. Q3 FY2020 earnings call
November 10, 2020 · fiscal period ended 2020-09
EPS · actual vs est
Revenue · actual vs est
Summary
Generated 2020-11-10
Management highlights
• Yuval noted the challenging third quarter with lenabasum studies in systemic sclerosis and cystic fibrosis not meeting primary endpoints, but lenabasum is active with valuable data on clinical benefit. • Barbara discussed post-hoc analyses showing clinical activity of lenabasum in scleroderma (improvement in lung function for those on established immunosuppressants) and cystic fibrosis (low pulmonary exacerbation rates in some regions). • Dermatomyositis is a key value driver for next year, with the Phase III DETERMINE study shortened to 28 weeks. • NIH-sponsored SLE study has enrolled 93 of 100 subjects, with top-line data expected in first half 2021. • Preclinical programs with CB2 agonists and new CB1 inverse agonists are highlighted, with focus on prioritizing programs for early data inflection points.
Segment performance
No detailed segment performance by product with revenue contribution provided in the transcript. The focus is on lenabasum and pipeline development.
Guidance
• Shortened the DETERMINE Phase III study for dermatomyositis from 1 year to 28 weeks to accelerate top-line data to spring 2021. • Anticipate top-line data from DM Phase III study in 2021 and data from SLE program next year. • Prioritizing pipeline programs for earliest data inflection points.
Risks
• Drug development risks, including studies not meeting primary endpoints as seen in systemic sclerosis and cystic fibrosis trials. • Uncertainties in clinical trial outcomes and regulatory approvals for new studies.
Q&A highlights
Q: About the dermatomyositis study, rationale for shortening and impact on conduct/powering?
A: Barbara explained that recent industry changes (shorter Phase III studies in dermatomyositis) led to shortening to 28 weeks. Blinded data shows ~85% improvement by Week 28, tradeoff not great, will provide inflection point sooner.
Q: Expand on CB1 inverse agonist 4001 limitations and next-gen compounds?
A: Barbara said 4001 was insoluble and had brain penetration issues. Next-gen compounds have better physical/chemical properties and no early concerns about brain accumulation.
Q: On systemic sclerosis trial, how to incorporate FVC findings into FDA label?
A: Barbara said they'll do additional data analysis, design new study, and work with regulators. Yuval added they'll engage with scleroderma experts and start regulatory path.
Q: On 4001 program, plans for multiple candidates or one?
A: Barbara said plan is to move the best-performing compound forward into clinical development, being conservative with resources.
Key numbers
Reported versus consensus
Earnings calendar feed
| Metric | Reported | Consensus | Delta | Prior year |
|---|---|---|---|---|
| EPS | $-12.91 | $-12.31 | -4.9% | — |
| Revenue | $1.2M | — | — | — |
Transcript
November 10, 2020Full transcript unavailable for redistribution
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